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NCT01854918 · ClinicalTrials.gov registry record · Phase 3
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,681
- Enrollment target
NCT01854918: Completed Phase 3 study, sponsored by Amgen.
NCT01854918 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 3,681 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (377% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01854918, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,681 participants
- Enrollment target
Study Summary
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
Primary Outcome
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
Interventions
- DRUG Standard of Care
- BIOLOGICAL Evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,681 participants |
| Start Date | 2013-04-23 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 3 |
What the finished NCT01854918 record still lists
NCT01854918 is an interventional study that assigns participants to a tested intervention. Its 3,681 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (377% higher).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT01854918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01854918 about?
NCT01854918 is a clinical study titled "Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia". This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.
What is the current status of trial NCT01854918?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,681 participants. The study started on 2013-04-23. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT01854918?
The interventions under investigation include: Standard of Care (DRUG), Evolocumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01854918?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01854918's enrollment target sits among peer trials
3,681 66th of 2000 higher than 1,935 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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